Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.

A complete guide to understanding cluster randomised trials Written by two researchers with extensive experience in the field, this book presents a complete guide to the design, analysis and reporting of cluster randomised trials. It spans a wide range of applications: trials in developing countries, trials in primary care, trials in the health services. A key feature is the use of R code and code from other popular packages to plan and analyse cluster trials, using data from actual trials. The book contains clear technical descriptions of the models used, and considers in detail the ethics involved in such trials and the problems in planning them. For readers and students who do not intend to run a trial but wish to be a critical reader of the literature, there are sections on the CONSORT statement, and exercises in reading published trials. * Written in a clear, accessible style * Features real examples taken from the authors extensive practitioner experience of designing and analysing clinical trials * Demonstrates the use of R, Stata and SPSS for statistical analysis * Includes computer code so the reader can replicate all the analyses * Discusses neglected areas such as ethics and practical issues in running cluster randomised trials How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research provides an excellent reference tool and can be read with profit by statisticians, health services researchers, systematic reviewers and critical readers of cluster randomised trials.

The bite of the tsetse fly - a burning sting into the skin - causes a descent into violent fever and aching pains. Severe bouts of insomnia are followed by mental deterioration, disruption of the nervous system, coma and ultimately death. Sleeping sickness, also known as Human African trypanosomiasis, is one of Africa's major killers. It puts 60 million people at risk of infection, occurs in 36 countries in sub-Saharan Africa, and claims the lives of many thousands of people every year. Transmitted by the tsetse fly, trypanosomiasis affects both humans and cattle. The animal form of the disease severely limits livestock production and farming, and in people the toxic effects of the treatment for the brain disease can be as painful and dangerous as the disease itself. Existing in the shadow of malaria and AIDS, it is an overlooked disease, ignored by pharmaceutical companies and largely neglected by the western world. Peter Kennedy has devoted much of his working life to researching sleeping sickness in Africa, and his autobiographical account shares not only his trials and experiences, evoking our empathy with the affected patients, but an explanation of the disease, including its history and its future. Interwoven with African geography, his compassionate story reveals what it is like to be a young doctor falling in love with Africa, and tells of his building of a vocation in the search for a cure for this cruel disease.

In spite of intensive investments and investigations carried out in the last decade, many aspects of the stem cell physiology, technology and regulation remain to be fully defined. After the enthusiasm that characterized the first decade of the discovery that when given the right cue, stem cells could repair all the different tissues in the body; it is now time to start a serious and coordinated action to define how to govern the stem cell potential and to exploit it for clinical applications. This can be achieved only with shared research programs involving investigators from all over the world and making the results available to all. The Disputationes Workshop series (http://disputationes.info) is an international initiative aimed at disseminating stem cell related cutting edge knowledge among scientists, healthcare workers, students and policy makers. The present book gathers together some of the ideas discussed during the third and fourth Disputationes Workshops held in Florence (Italy) and Aalborg (Denmark), respectively. The aim of this book is to preserve those ideas in order to contribute to the general discussion on organ repair and to bolster a fundamental scientific and technological leap forwards the treatment of otherwise incurable diseases.

Polycyclic aromatic hydrocarbons, many of which have been identified as potent human carcinogens, occur widely in the environment as a result of incomplete combustion of fossil fuels and other organic matter. Major sources of emissions arise from wood and coal burning, automobiles, heat and power plants, and refuse burning. Their widespread occurrence in the air and in food and water underlines the importance of understanding their role as causes of human cancer. This 1991 volume was the first to review the chemical properties of these carcinogens and to relate their carcinogenic activity to their metabolic by-products within the body. The emphasis throughout is on those recent findings, newer methods and techniques which helped to illuminate the process of carcinogenesis. The volume is suitable for anyone with a professional interest in the chemistry and metabolism of polycyclic aromatic hydrocarbons, environmental chemistry and chemical carcinogenesis.

This book was first published in 2002. It presents an overview of ethnic and racial differences in response to medications and offers insight into the genetic and non-genetic reasons for these differences. The roles of pharmacogenomics and pharmacogenetics in drug development, regulatory aspects of representing minorities in clinical trials, as well as NIH, ICH and FDA guidelines as they pertain to these issues are examined in detail. Finally, various strategies to increase recruitment and retention of minority populations in clinical trials are considered.

In this issue of Clinics in Laboratory Medicine, guest editor Dr. Fei Dong brings his considerable expertise to the topic of Molecular Oncology Diagnostics. Top experts in the field review current practices in molecular oncology diagnostics, highlighting the rapid clinical adoption of next generation sequencing techniques. The articles address key laboratory considerations in the molecular testing of cancer specimens and the impact of advanced testing strategies on patient care. Contains 15 practice-oriented topics including utility of single gene testing in cancer specimens; analytical principles of cancer next generation sequencing; principles and validation of bioinformatics pipelines for cancer next generation sequencing; panel sequencing for targeted therapy selection in solid tumors; and more. Provides in-depth clinical reviews on molecular oncology diagnostics, offering actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews.

Demystifies Biomedical and Biological Big Data Analyses Big Data Analysis for Bioinformatics and Biomedical Discoveries provides a practical guide to the nuts and bolts of Big Data, enabling you to quickly and effectively harness the power of Big Data to make groundbreaking biological discoveries, carry out translational medical research, and implement personalized genomic medicine. Contributing to the NIH Big Data to Knowledge (BD2K) initiative, the book enhances your computational and quantitative skills so that you can exploit the Big Data being generated in the current omics era. The book explores many significant topics of Big Data analyses in an easily understandable format. It describes popular tools and software for Big Data analyses and explains next-generation DNA sequencing data analyses. It also discusses comprehensive Big Data analyses of several major areas, including the integration of omics data, pharmacogenomics, electronic health record data, and drug discovery. Accessible to biologists, biomedical scientists, bioinformaticians, and computer data analysts, the book keeps complex mathematical deductions and jargon to a minimum. Each chapter includes a theoretical introduction, example applications, data analysis principles, step-by-step tutorials, and authoritative references.

"Laboratory Animals: Regulations and Recommendations for Global Collaborative Research" is the only publication to offer a compilation of standards across the world in the care, welfare and use of animals in research. Timely in the new legislation in numerous regions of the world, this book provides the information in easily accessible, readable language.

For professionals across laboratory animal science and biomedical research, "Laboratory Animals: Regulations and Recommendations for Global Collaborative Research" provides a broad picture of the regulations required in other areas of the world and is essential to appropriately manage animal care and use programs.
Offers a worldwide view and global compilation of regulations, guidelines and recommendations for laboratory animal researchSaves valuable time researching different regional legislation and regulationsProvides insight into factors that play roles in the regulatory framework for countries and geographic regionsWritten in "layman s" terms to easily understand legislation and regulations"

This issue of "International Review of Neurobiology" brings together cutting-edge research on tissue engineering of the peripheral nerve. It reviews current knowledge and understanding, provides a starting point for researchers and practitioners entering the field, and builds a platform for further research and discovery.
This volume of "International Review of Neurobiology" brings together cutting-edge research on tissue engineering of the peripheral nerve. It reviews current knowledge and understanding, provides a starting point for researchers and practitioners entering the field, and builds a platform for further research and discovery.

This second edition of a pioneering technical work in biomedical informatics provides a very readable treatment of the deep computational ideas at the foundation of the field. "Principles of Biomedical Informatics, "2nd Edition is radically reorganized to make it especially useable as a textbook for courses that move beyond the standard introductory material. It includes exercises at the end of each chapter, ideas for student projects, and a number of new topics, such as: tree structured data, interval trees, and time-oriented medical data and their use On Line Application Processing (OLAP), an old database idea that is only recently coming of age and finding surprising importance in biomedical informatics a discussion of nursing knowledge and an example of encoding nursing advice in a rule-based system X-ray physics and algorithms for cross-sectional medical image reconstruction, recognizing that this area was one of the most central to the origin of biomedical computing an introduction to Markov processes, and an outline of the elements of a hospital IT security program, focusing on fundamental ideas rather than specifics of system vulnerabilities or specific technologies.

It is simultaneously a unified description of the core research concept areas of biomedical data and knowledge representation, biomedical information access, biomedical decision-making, and information and technology use in biomedical contexts, and a pre-eminent teaching reference for the growing number of healthcare and computing professionals embracing computation in health-related fields.

As in the first edition, it includes many worked example programs in Common LISP, the most powerful and accessible modern language for advanced biomedical concept representation and manipulation.

The text also includes humor, history, and anecdotal material to balance the mathematically and computationally intensive development in many of the topic areas. The emphasis, as in the first edition, is on ideas and methods that are likely to be of lasting value, not just the popular topics of the day. Ira Kalet is Professor Emeritus of Radiation Oncology, and of Biomedical Informatics and Medical Education, at the University of Washington. Until retiring in 2011 he was also an Adjunct Professor in Computer Science and Engineering, and Biological Structure. From 2005 to 2010 he served as IT Security Director for the University of Washington School of Medicine and its major teaching hospitals. He has been a member of the American Medical Informatics Association since 1990, and an elected Fellow of the American College of Medical Informatics since 2011. His research interests include simulation systems for design of radiation treatment for cancer, software development methodology, and artificial intelligence applications to medicine, particularly expert systems, ontologies and modeling.
* Develops principles and methods for representing biomedical data, using information in context and in decision making, and accessing information to assist the medical community in using data to its full potential
* Provides a series of principles for expressing biomedical data and ideas in a computable form to integrate biological, clinical, and public health applications
* Includes a discussion of user interfaces, interactive graphics, and knowledge resources and reference material on programming languages to provide medical informatics programmers with the technical tools to develop systems"

This book provides an in-depth description and discussion of different multi-modal diagnostic techniques for cancer detection and treatment using exact optical methods, their comparison, and combination. Coverage includes detailed descriptions of modern state of design for novel methods of optical non-invasive cancer diagnostics; multi-modal methods for earlier cancer diagnostic enhancing the probability of effective cancer treatment; modern clinical trials with novel methods of clinical cancer diagnostics; medical and technical aspects of clinical cancer diagnostics, and long-term monitoring. Biomedical engineers, cancer researchers, and scientists will find the book to be an invaluable resource. Introduces optical imaging strategies; Focuses on multimodal optical diagnostics as a fundamental approach; Discusses novel methods of optical non-invasive cancer diagnostics.

"The Path from Biomarker Discovery to Regulatory Qualification "is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science.

For complimentary access to chapter 13, "'""Classic' Biomarkers of Liver Injury, " by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http: //tinyurl.com/ClassicBiomarkers
Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science

Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use

Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities. "

Antipsychotic medications are a key treatment for schizophrenia and sales of antipsychotic drugs approach $20 billion per year, with fierce marketing between the makers of the drugs. The U.S. National Institute of Mental Health sponsored the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project to provide independent information about the comparative effectiveness of medications. CATIE was the largest, longest and most comprehensive study of schizophrenia to date. Conducted under rigorous double-blind conditions, Antipsychotic Trials in Schizophrenia presents the definitive archival results of this landmark study. The core of the book consists of chapters focused on specific outcomes that set the CATIE findings in a wider context. Also included are chapters on the design, statistical analyses and implications for researchers, clinicians and policy makers. Psychiatrists, psychiatric researchers, mental health policy makers and those working in pharmaceutical companies will all find this to be essential reading.

Health professionals are increasingly drawn towards research in the course of their training, often with little guidance on the skills and techniques required. This practical text provides essential advice to guide the beginner through the processes involved in selecting, organizing, funding, undertaking, evaluating and publishing a biomedical research project, and completing a postgraduate qualification. Cartoon illustrations provide a wry commentary on the ups and downs of life in research. This edition contains new content on choosing supervisors, career implications, degree structures, ethical issues and time conflicts between research and service needs, and is fully revised and updated to reflect changes in the structure of medical careers and degree courses, and the use of computational and information technology in research presentation. An invaluable guide suitable for all stages of a medical research career, from the first stages of research, through to professional supervisors, career counselors and postgraduate tutors.

A Davis's Notes Title! Here's the portable reference you need to explain, prepare, and care for patients before, during, and after common lab and diagnostic testing. What students and clinicians are saying: "Great easy to use reference for reviewing in your down-time or when you need to assemble your plan of care. Very concise but at the same time comprehensive enough that I don't find myself scrambling to supplement the information with other texts." - B. Khasky, Amazon.com "I find this book to be most helpful in the clinical setting. The size is perfect for carrying in your scrub pocket for frequent reference. I recommend it to all of my students." - Sarah Barra, Amazon.com "Perfect to take along to clinicals or just to look over before exams! I love how the book has erasable pages in case you need to make a note some where you can easily erase it later on. This book was a life saver to be able to just quickly pull it out and have the information readily available. I would highly recommend this book to anyone in the nursing program or anyone who is new to the nursing field and not 100% sure of what norms should be." - Amazon Customer, Amazon.com

In recent years, high-density DNA microarrays have revolutionized biomedical research and drug discovery efforts by the pharmaceutical industry. Their efficacy in identifying and prioritizing drug targets based on their ability to confirm a large number of gene expression measurements in parallel has become a key element in drug discovery. Microarray Innovations: Technology and Experimentation examines the incredibly powerful nature of array technology and the ways in which it can be applied to understanding the genomic basis of disease. Explores a myriad of applications in use today This volume explores recent innovations in the microarray field and tracks the evolution of the major platforms currently used. The international panel of contributors presents a survey of the past five years' research and advancements in microarray methods and applications and their usage in drug discovery and biomedical research. The contributions discuss improvements in automation (array fabrication and hybridization), new substrates for printing arrays, platform comparisons and contrasts, experimental design, and data normalization and mining schemes. They also review epigenomic array studies, electronic microarrays, comparative genomic hybridization, microRNA arrays, and mutational analyzes. In addition, the book provides coverage of important clinical diagnostic arrays, protein arrays, and neuroscience applications. Examines improved methodologies As microarrays have evolved steadily over time from archetypical in-house complementary DNA (cDNA) arrays to robust commercial oligonucleotide platforms, there has been a migration to higher density biochips with increasing content and better analytical methodologies. This compendium summarizes the vast advances that have been made in this technology, highlighting the supreme advantages of microarray-based appro

Evaluators who are interested in developing or improving a program or policy frequently look to formative evaluation as a guiding framework. This book shows why those hoping to use evaluation to drive change in complex systems, rather than develop or improve one program, policy, or product, need to shift from the oversimplified idea of formative evaluation to a more specified continuous improvement model grounded in improvement science. In doing so, author Kristen L. Rohanna provides guidance to both evaluators and others, such as K-12 educators or hospital administrators, who lead improvement initiatives in their organizations and seek to solve persistent problems of practice. The book includes an extended case study: a networked improvement community of five public middle and high schools.

Written by dedicated and active professionals from different areas of the pharmaceutical, biomedical, and medtech sectors, this book provides information on job and career opportunities in various life sciences industries. It also contains useful tips to launch your own startup. The pharmaceutical, biomedical and medical technology sectors offer a wide range of employment opportunities to talented and motivated young graduates. However, many of these employment prospects are not well known to early career scientists, who concentrate primarily on the scientific and academic content of their fields of interest. The book is divided into five parts: Part 1 provides an academic perspective that focuses on the specific preparation required in the final years of study to embark on a successful career in the pharmaceutical and biomedical industries. In Part 2, industry experts discuss employment possibilities all along the drug or product life cycle, from discovery research and development to commercialisation. Part 3 follows, highlighting opportunities in support functions such as regulatory affairs or quality assurance. Part 4 focuses on additional opportunities in the wider biomedical sector, while Part 5 contains practical tips and training opportunities for entering the pharmaceutical and biomedical industries. In the epilogue, the authors reflect on this fascinating field and its career prospects. The book offers a multidisciplinary perspective on career opportunities in the pharmaceutical and biomedical industry to a wide range of students and young life scientists.

Advances in medicine have brought us the stethoscope, artificial kidneys, and computerized health records. They have also changed the doctor-patient relationship. This book explores how the technologies of medicine are created and how we respond to the problems and successes of their use. Stanley Joel Reiser, MD, walks us through the ways medical innovations exert their influence by discussing a number of selected technologies, including the X-ray, ultrasound, and respirator. Reiser creates a new understanding of thinking about how health care is practiced in the United States and thereby suggests new methods to effectively meet the challenges of living with technological medicine. As healthcare reform continues to be an intensely debated topic in America, Technological Medicine shows us the pros and cons of applying technological solutions health and illness.

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon. Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.

A True Insider's Guide to the Field - Then and Now Until now, there has not been a book that effectively addresses the historical basis of protein discovery. Featuring contributions from a distinguished international panel of experts, Protein Discovery Technologies elucidates the principles, techniques, strategies, and broad range of applications of protein discovery by documenting the often untold stories and personal accounts of the contributors' past scientific achievements. Incorporates Short, Personal Discovery Vignettes Rather than an exhaustive field analysis, this globally pertinent resource presents in-depth discussions of various methods for protein discovery, including bioinformatics, interaction cloning, protein purification, phage display, non-primate models, and chemical targeting. It also explores biological themes through the examination of cell death, angiogenesis, hemostasis, development, signal transduction, transcriptional control, cell cycle control, neurobiology, and quality control. This readily accessible resource discusses an array of interesting topics, including: Tumor necrosis factors The origin of interferon as an angiogenesis inhibitor In vivo combinatorial mapping of vascular zip codes Extracellular matrix degradome as regulators of angiogenesis and tumor growth A matricellular protein prototype The use of RING finger proteins as E3 Ubiquitin Ligases Whereas most books tend to be more specialized, this book contains a broad view of the protein discoveries in many different fields, making Protein Discovery Technologies a valuable reference for today's researchers, both the new and more seasoned, who are seeking a newfound perspective or a deeper understanding of this exciting field.

Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical foundation of adaptive design theory. The book focuses on designing sequential randomized experiments to compare two or more treatments incorporating information accrued along the way. The authors first introduce the terminology and statistical models most commonly used in comparative experiments. They then illustrate biased coin and urn designs that only take into account past treatment allocations as well as designs that use past data, such as sequential maximum likelihood and various types of doubly adaptive designs. The book also covers multipurpose adaptive experiments involving utilitarian choices and ethical issues. It ends with adaptive methods that include covariates in the design. The appendices present basic tools of optimal design theory and address Bayesian adaptive designs. This book helps readers fully understand the theoretical properties behind various adaptive designs. Readers are then equipped to choose the best design for their experiment.

Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." - Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women's health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.